There are 6 major categories of food facilities that are exempt from HARPC.
The first major exemption relates to food companies under the exclusive jurisdiction of the U.S. Department of Agriculture (those handling, processing, shipping meat, poultry, pork, eggs, etc.).
The second major exemption is for companies that are subject to FDA’s new Standards for Produce Safety authorities, which were also created by FSMA. This exemption applies to farms, cooperatives, growers, harvesters and other companies handling raw fresh fruits and vegetables.
The third major exemption applies to facilities that are subject to and comply with FDA’s seafood and juice HACCP regulations.
The fourth, more limited exemption, involves low acid and acidifed canned food processors, but only as the regulatory controls govern and control certain aspects of microbiological contamination (e.g., botulism).
The fifth group of exempt companies includes those defined as “small” or “very small” businesses. FDA is required to define these terms by regulation.
Sixth and last, and very similar to the immediately previous exemption, is the group of companies with a previous 3-year average product value of less than $500,000. FDA may also, by future regulations, exempt facilities that solely produce food for animals, store raw agricultural commodities (other than fruits and vegetables) intended for further processing or that store packaged foods that are not exposed to the environment.